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A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer

18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer

In the currently proposed study, patients will receive the first dose of the vaccine
approximately 2 weeks prior to surgery. The second dose will be administered about 3-4 weeks
following surgery. A booster dose of the vaccine will be given 6 months after the 2nd
vaccine. The tumor tissue and serum will be studied for immunological responses following
therapy with the vaccine. Patients are allowed to receive adjuvant chemotherapy if
indicated. The choice of the chemotherapy regimen will be at the discretion of the treating
physician, preferably 3-4 cycles of platinum combination regimen. The vaccine should be
administered at least 2 weeks before chemotherapy is initiated.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed non-small cell lung

- All patients must have one of the following stages: Stage IA(T1NO), and IB T2NO), II
& IIIA (N2 negative)

- No prior chemotherapy or radiation therapy for non-small cell lung cancer

- Age >18 years

- ECOG performance status <2

- Patients must have acceptable organ and marrow

- Patient must be deemed surgically and medically resectable

- Men and women of childbearing potential must be willing to use effective
contraception while on treatment and for at least 3 months thereafter.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients may not be receiving any other investigational agents.

- Patients should not have received chemotherapy or radiotherapy within 3 months prior
to entry to study.

- Patients with tumors involving the superior sulcus are not eligible.

- Patients must not have post-obstructive pneumonia or other serious infection at the
time of registration or other serious underlying medical condition that would impair
the ability of the patient to receive protocol treatment.

- Prior resection of lung cancer is allowed, if at least five years have elapsed
between previous resection and registration.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study. Women of childbearing potential must
have a negative pregnancy test.

- Known HIV-positive patients are excluded from the study.

- Patients with a history of known autoimmune disease are excluded from this study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response.

Outcome Time Frame:

One week after second vaccine

Safety Issue:


Principal Investigator

Chandra P. Belani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:

PSHCI 08-008



Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • early stage non-small cell lung cancer
  • non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms